NCT04457973

Brief Summary

The purpose of this project is to evaluate the preliminary effects of home-based M1-SO applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain management in persons with early-stage AD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 4, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

October 13, 2023

Completed
Last Updated

October 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

July 1, 2020

Results QC Date

August 23, 2023

Last Update Submit

September 20, 2023

Conditions

Alzheimer's Disease and Related Dementias

Outcome Measures

Primary Outcomes (1)

  • Pain as Assessed by the Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) Scale

    Mobilization-Observation-Behavior-Intensity-Dementia (MOBID-2) is a 10 question scale, each question rated from 0-10. The total score ranges between 0-100 with a higher number indicating a worse outcome. The change in total score between the baseline (day 1) and the end of intervention (day 5) is reported.

    baseline (day 1), end of intervention (day 5)

Secondary Outcomes (6)

  • Clinical Pain as Assessed by a Numerical Rating Scale (NRS)

    baseline (day 1), end of intervention (day 5)

  • Behavioral and Psychological Symptoms of Dementia (BPSD) as Measured by the Cohen-Mansfield Agitation Inventory (CMAI)

    baseline (day 1), end of intervention (day 5)

  • Behavioral and Psychological Symptoms as Assessed by Neuropsychiatric Inventory (NPI)

    baseline (day 1), end of intervention (day 5)

  • Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System

    baseline (day 1), end of intervention (day 5)

  • Acceptability as Measured by the tDCs Experience Questionnaire

    end of intervention (day 5)

  • +1 more secondary outcomes

Study Arms (2)

Active tDCS

EXPERIMENTAL
Device: Active tDCS

Sham tDCS

PLACEBO COMPARATOR
Device: Sham tDCS

Interventions

Active tDCSDEVICE

tDCS with a constant current intensity of 2 milliampere (mA) will be applied for 20 minutes per session daily for 5 days via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and 5x7 cm saline-soaked surface sponge electrodes.

Active tDCS
Sham tDCSDEVICE

The electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.

Sham tDCS

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • early-stage Alzhimer's disease and related dementias (ADRD)
  • have caregiver-reported chronic pain (average pain in the past 3 months ≥ 3 out of 10),
  • have a caregiver willing to participate in the study who sees the participant at least 10 hours/week
  • can speak and read English
  • have no plans to change medication regimens during the trial

You may not qualify if:

  • history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
  • alcohol/substance abuse
  • severely diminished cognitive function (i.e., MiniMental Status Exam score ≤ 15)
  • hospitalization within the preceding year for neuropsychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Hyochol Ahn
Organization
University of Arizona
hbrian@arizona.edu
520-626-1769

Study Officials

  • Hyochol Ahn, RN,PhD,MSN

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean for Research & Professor

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

September 4, 2020

Primary Completion

October 19, 2022

Study Completion

October 19, 2022

Last Updated

October 13, 2023

Results First Posted

October 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)